Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-0610-2020)

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Class I

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 2039151, 2039153, 2039158, 2039164, 2039174, 2039178, 2039181, 2039182, 2039183, 2039187, 2039202, 2039203, 2039204, 2039208, 2039209, 2039210, 2039211, 2039212, 2039216, 2039217, 2039220, 2039221, 2039223, 2039225, 2039226, 2039228, 2039231, 2039232, 2039234, 2039235, 2039236, 2039238, 2039239, 2039246, 2039247, 2039248, 2039250, 2039252, 2039259, 2039290, 2039291, 2039292, 2039295, 2039305, 2039307, 2039308, 2039312, 2039313, 2039315, 2039317, 2039323, 2039325, 2039360, 2039373, 2039394, 2039407, 2039416, 2039419, 2039420, 2039422, 2039435, 2039437, 2039446, 2039453, 2039456, 2039460, 2039461, 2039462, 2039463, 2039464, 2039465, 2039466, 2039469, 2039473, 2039478, 2039483, 2039485, 2039487, 2039490, 2039494, 2039502, 2039503, 2039516, 2039517, 2039545, 2039551, 2039904, 2039910, 2039970, 2040014, 2040029, 2040034, 2040040, 2040047, 2040050, 2040054, 2040068, 2040074, 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CO, MD, NY

Voluntary: Firm initiated